Ignite Creation Date:
2025-12-24 @ 3:52 PM
Ignite Modification Date:
2025-12-26 @ 11:57 PM
Study NCT ID:
NCT03916692
Status:
TERMINATED
Last Update Posted:
2022-09-08
First Post:
2019-04-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
GRAPE • Glycemic Response of Amylopectin Containing Drinks
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'Randomized Cross-over trial'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 15}}, 'statusModule': {'whyStopped': 'Covid-19 restrictions', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2019-04-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-09', 'completionDateStruct': {'date': '2021-08-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-09-07', 'studyFirstSubmitDate': '2019-04-12', 'studyFirstSubmitQcDate': '2019-04-12', 'lastUpdatePostDateStruct': {'date': '2022-09-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-04-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-08-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Area Under the Curve of Glucose', 'timeFrame': '120 minutes', 'description': 'Positive integer of the area under the Curve of glucose'}, {'measure': 'Area Under the Curve for Insulin', 'timeFrame': '120 minutes', 'description': 'Positive integer of the area under the Curve of insulin'}, {'measure': 'Blood glucose', 'timeFrame': '30, 60 and 120 minutes of the glucose challenge', 'description': 'Blood glucose levels'}, {'measure': 'Blood insulin', 'timeFrame': '30, 60 and 120 minutes of the glucose challenge', 'description': 'Blood insulin levels'}], 'secondaryOutcomes': [{'measure': 'c-peptide', 'timeFrame': '30, 60, and 120 minutes of the glucose challenge', 'description': 'Blood levels of c-peptide'}, {'measure': 'glucagon', 'timeFrame': '30, 60, and 120 minutes of of the glucose challenge', 'description': 'Blood levels of glucagon'}, {'measure': 'Leptin', 'timeFrame': '30, 60, and 120 minutes of the glucose challenge', 'description': 'Blood levels of leptin'}, {'measure': 'Adiponectin', 'timeFrame': '30, 60, and 120 minutes of the glucose challenge', 'description': 'Blood levels of adiponectin'}, {'measure': 'glucagon-like-peptide-1', 'timeFrame': '30, 60, and 120 minutes of the glucose challenge', 'description': 'Blood levels of glucagon-like-peptide-1'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Glycemic Index']}, 'descriptionModule': {'briefSummary': 'To quantify the glycemic index of the SP energy-smart-based nutrition supplement and the SP Glucose-support formula as compared to a glucose drink. We hypothesized that both the energy-smart-based nutritional supplement and the SP Glucose-support formula will have low glycemic index.\n\nThe aim of the study is to quantify the glycemic index of the SP energy-smart-based nutrition supplement and the SP Glucose-support formula as compared to a glucose drink. We hypothesized that both the energy-smart-based nutritional supplement and the SP Glucose-support formula will have low glycemic index.', 'detailedDescription': 'Subjects: 9 non-diabetic (HbA1c \\< 6.5) males aged 30-55 years with body mass indices ranging from 27.5 to 35 kg∙m-2. Individuals with impaired glucose tolerance will be included as long as they are not diagnosed with diabetes and their HbA1c is less than 6.5.\n\nPreliminary Testing: Medical history, weight, height, body composition via dual x-ray absorptiometry (DXA) and glycosylated hemoglobin (HbA1c) measurement.\n\nProtocol: After a 10-hour overnight fast, subjects will complete 3 experimental visits in which they will ingest one of three beverages in a randomized order. During experimental visits subjects will either be given the following 3 experimental drinks:\n\n* Full SP-glucose balance formula (200 kcal)\n* Energy smart carbohydrate blend (50 g, 200 kcal)\n* Liquid dextrose solution in the form of TRUTOL ® Glucose Tolerance Test Beverage (50 g, 200 kcal)'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '30 Years', 'genderBased': True, 'genderDescription': 'self-reported', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* BMI 27.5 to 35 kg∙m-2\n\nExclusion Criteria:\n\n* Diagnosed diabetes\n* HbA1c \\> 6.5\n* competitive athletes\n* body weigh change \\> 3kg during last month'}, 'identificationModule': {'nctId': 'NCT03916692', 'acronym': 'GRAPE', 'briefTitle': 'GRAPE • Glycemic Response of Amylopectin Containing Drinks', 'organization': {'class': 'OTHER', 'fullName': 'Arizona State University'}, 'officialTitle': 'Glycemic Response of Amylopectin Containing Drinks', 'orgStudyIdInfo': {'id': 'FP00016578'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Standard Process - glucose balance', 'description': 'Standard Process - glucose balance formula (200 kcal)', 'interventionNames': ['Dietary Supplement: Carbohydrate drink']}, {'type': 'EXPERIMENTAL', 'label': 'Energy smart Carbohydrate blend', 'description': 'Energy smart carbohydrate blend (50 grams, 200 kcal)', 'interventionNames': ['Dietary Supplement: Energy smart Carbohydrate blend']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Liquid Dextrose Control', 'description': 'Liquid dextrose solution in the form of TRUTOL ® Glucose Tolerance Test Beverage (50 grams, 200 kcal)', 'interventionNames': ['Dietary Supplement: Liquid Dextrose']}], 'interventions': [{'name': 'Carbohydrate drink', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['SP-glucose balance formula'], 'description': 'Meal replacement drink containing 200 kcal', 'armGroupLabels': ['Standard Process - glucose balance']}, {'name': 'Energy smart Carbohydrate blend', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Carbohydrate blend drink designed for low glycemic responses containing 200 kcal', 'armGroupLabels': ['Energy smart Carbohydrate blend']}, {'name': 'Liquid Dextrose', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Liquid Dextrose drink of 200 kcal', 'armGroupLabels': ['Liquid Dextrose Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85004', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Arizona Biomedical Collaborative', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}], 'overallOfficials': [{'name': 'Stavros Kavouras, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Arizona State University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Arizona State University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Standard Process Inc.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}